Catalog Number

441925

Brand Name

Control Set for the BD ProbeTec™ CT/GC/TV Qx Amplified DNA Assays

Version/Model Number

441925

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

Yes

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K130268

Product Code

OUY

Product Code Name

Trichomonas vaginalis nucleic acid amplification test system

Public Device Record Key

9c61dd9b-1f23-4f95-8753-60ac55559a25

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

July 07, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-